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Medical Device Quality System Solutions

Irvine, United States (US) · Manufacturing and Industry

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Medical Device Quality System Solutions is a US-based consulting firm specializing in quality systems and compliance solutions for the medical device industry.We support medical device companies navigating the complexities of regulatory requirements, including FDA 21 CFR 820, ISO 13485, ISO 9001, MDD, MD SAP, and the EU MDR.

Overview

Medical Device Quality System Solutions is a US-based consulting firm specializing in quality systems and compliance solutions for the medical device industry.

We support medical device companies navigating the complexities of regulatory requirements, including FDA 21 CFR 820, ISO 13485, ISO 9001, MDD, MD SAP, and the EU MDR. Our team provides expert guidance on quality system restructuring, change control, CAPA, complaint management, and audit readiness.

MDQSS offers tailored solutions to address specific challenges, from gap assessments and documentation updates to internal audits and technical file preparation for Notified Bodies. We are committed to helping our clients achieve and maintain compliance, ensuring the safety and efficacy of their medical devices.
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Contact Details

info@mdqss.com

Irvine, United States (US)

Founded

2019

Company Type

Sole Proprietorship

Employees

2-10

Categories

Manufacturing
Medical Equipment and Services
Medical Technology Solutions

Awards

• 2026 OpenSee all

Services

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EU MDR Technical Documentation and Notified Body …
Medical Equipment and Services

Our team of experts can help your organization with preparing or reviewing documentation for EU MDR technical files, as well as, providing support with Notified Body submissions and questions on the submitted EU MDR technical file documentation.

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